Novartis Announces NMPA Approval of Secukinumab for Ankylosing Spondylitis in China

On April 28, Novartis China announced that Cosentyx (secukinumab) had been approved by the National Medical Products Administration for the treatment of adult patients with ankylosing spondylitis who have had an inadequate response to conventional therapy. This marks the first and only interleukin inhibitor currently approved in China for the treatment of ankylosing spondylitis.

The results of the MEASURE 2 study demonstrated that Cosentyx rapidly alleviates symptoms of back pain, morning stiffness, and fatigue; inhibits new bone formation; and prevents structural damage. Patients were randomized to receive either 150 mg of Cosentyx or placebo through Week 4. At Week 4, back pain improved by 39% from baseline in the treatment group compared with 15% in the placebo group; morning stiffness improved by 34.4% from baseline in the treatment group compared with 14.8% in the placebo group; and fatigue improved by 28% from baseline in the treatment group compared with 8% in the placebo group. Clinical findings revealed that 80% of patients treated with Cosentyx had no new syndesmophytes over 2 years, and nearly 80% showed no progression of spinal damage over 4 years. The results demonstrated a favorable overall safety and tolerability profile. Among patients treated with Cosentyx, there were no reports of increased susceptibility to tuberculosis, no reports of hepatitis B reactivation, and the incidence of anti-drug antibodies was less than 1% over 5 years.

Ankylosing spondylitis is a chronic inflammation occurring in the spine, characterized by a prolonged disease course. As the condition worsens, patients may lose most of their mobility. Susceptibility genes and family history are the primary pathogenic factors for ankylosing spondylitis; therefore, the number of patients with this condition in China has remained relatively stable. According to Frost & Sullivan, the number of ankylosing spondylitis patients in China increased from 3.76 million in 2014 to 3.85 million in 2018, representing a compound annual growth rate (CAGR) of 0.6% during this period. The number of patients is projected to reach 3.955 million by 2023, with a CAGR of 0.5%, and will continue to grow at a CAGR of 0.4%, reaching 4.054 million by 2030.

Secukinumab (brand name: Cosentyx; commonly known as "Su Jin Dan Kang") is a fully human IgG1κ monoclonal antibody targeting IL-17A, developed by Novartis. It was approved by the FDA for marketing in 2015 and is currently available in more than 80 countries and regions, including EU member states and the United States. Its indications include psoriatic arthritis (PsA), plaque psoriasis (PsO), and ankylosing spondylitis (AS).

IL-17A is a core pathogenic factor involved in the inflammation and disease progression of psoriasis, psoriatic arthritis, and ankylosing spondylitis. IL-17A can be produced via both IL-23-dependent and IL-23-independent pathways by various cells of the innate and adaptive immune systems. By directly targeting IL-17A from diverse sources, secukinumab has demonstrated sustained efficacy and safety across all domains of psoriasis, including nail, scalp, palmoplantar, and joint involvement.

Secukinumab is one of the first batches of overseas new drugs urgently needed for clinical use in China. It was approved by the National Medical Products Administration (NMPA) in March 2019 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and was officially launched in China in May of the same year. The new indication for ankylosing spondylitis (Acceptance No.: JXSS1900025) was submitted for marketing approval in May 2019 and included in the priority review program in August.

Secukinumab’s outstanding performance in the fields of psoriasis and ankylosing spondylitis made it Novartis’ best-selling drug in 2019, with global sales reaching $3.55 billion, a year-on-year increase of 25%.

References: CPhI Online, Immediate Pharma News